TY - JOUR
T1 - Efficacy and safety of oral mirodenafil in the treatment of erectile dysfunction in diabetic men in Korea
T2 - A multicenter, randomized, double-blind, placebo-controlled clinical trial
AU - Park, Hyun Jun
AU - Choi, Hyung Ki
AU - Ahn, Tai Young
AU - Park, Jong Kwan
AU - Chung, Woo Sik
AU - Lee, Sung Won
AU - Kim, Sae Woong
AU - Hyun, Jae Seog
AU - Park, Nam Cheol
N1 - Funding Information:
This study was sponsored by SK Chemicals Corporation, Seoul, Korea (Study No: SK3530_DM_ III_ 2007).
PY - 2010/8
Y1 - 2010/8
N2 - Introduction. Mirodenafil is a newly developed selective phosphodiesterase type 5 (PDE5) inhibitor for the treatment of erectile dysfunction (ED). Aim. To evaluate the efficacy, safety and tolerability of mirodenafil in the treatment of ED in Korean men with diabetes. Methods. A multicenter, randomized, double-blind, placebo-controlled, parallel-group, fixed-dose study was conducted with 112 subjects who were randomized to either placebo or mirodenafil 100 mg on demand for 12 weeks. Main Outcome Measures: Primary efficacy variable was the erectile function (EF) domain scores of the International Index of Erectile Dysfunction (IIEF) questionnaire. Secondary efficacy variables included change in the scores of IIEF question 3 and 4 (IIEF Q3 and Q4) from baseline, change in all domain scores in the IIEF from baseline, Sexual Encounter Profile questions 2 and 3 (SEP2 and SEP3), the Global Assessment Question (GAQ) and the Life Satisfaction Checklist (LSC). Results. After 12 weeks of treatment, mirodenafil group showed significantly greater change in the IIEF-EF domain score from baseline compared with the placebo group (9.3 vs. 1.4, P < 0.0001). The changes from baseline in the mirodenafil group in IIEF Q3 (1.7 vs. 0.4, P < 0.0001) and Q4 (1.7 vs. 0.3, P < 0.0001) were higher compared with the placebo group. Differences between the mirodenafil and placebo groups were significant in the SEP2 (82.0% vs. 55.2%, P = 0.0003), SEP3 (68.9% vs. 22.3%, P < 0.0001). Difference in GAQ "YES" responses was also significant (76.9% vs. 19.1%, P < 0.0001). Normal EF domain scores (≥26) at study end were achieved by 32.7% and 9.4% in the mirodeniafl and placebo groups, respectively (P = 0.0031). As for the LSC scores, the mirodenafil group showed significantly greater improvements in sexual life and partner relationship than the placebo group. Most treatment-associated AEs were mild that resolved spontaneously. Conclusions. Mirodenafil is an effective and well-tolerated agent for the treatment of diabetic patients with ED in Korea. Park HJ, Choi HK, Ahn TY, Park JK, Chung WS, Lee SW, Kim SW, Hyun JS, and Park NC. Efficacy and safety of oral mirodenafil in the treatment of erectile dysfunction in diabetic men in Korea: A multicenter, randomized, double-blind, placebo-controlled clinical trial.
AB - Introduction. Mirodenafil is a newly developed selective phosphodiesterase type 5 (PDE5) inhibitor for the treatment of erectile dysfunction (ED). Aim. To evaluate the efficacy, safety and tolerability of mirodenafil in the treatment of ED in Korean men with diabetes. Methods. A multicenter, randomized, double-blind, placebo-controlled, parallel-group, fixed-dose study was conducted with 112 subjects who were randomized to either placebo or mirodenafil 100 mg on demand for 12 weeks. Main Outcome Measures: Primary efficacy variable was the erectile function (EF) domain scores of the International Index of Erectile Dysfunction (IIEF) questionnaire. Secondary efficacy variables included change in the scores of IIEF question 3 and 4 (IIEF Q3 and Q4) from baseline, change in all domain scores in the IIEF from baseline, Sexual Encounter Profile questions 2 and 3 (SEP2 and SEP3), the Global Assessment Question (GAQ) and the Life Satisfaction Checklist (LSC). Results. After 12 weeks of treatment, mirodenafil group showed significantly greater change in the IIEF-EF domain score from baseline compared with the placebo group (9.3 vs. 1.4, P < 0.0001). The changes from baseline in the mirodenafil group in IIEF Q3 (1.7 vs. 0.4, P < 0.0001) and Q4 (1.7 vs. 0.3, P < 0.0001) were higher compared with the placebo group. Differences between the mirodenafil and placebo groups were significant in the SEP2 (82.0% vs. 55.2%, P = 0.0003), SEP3 (68.9% vs. 22.3%, P < 0.0001). Difference in GAQ "YES" responses was also significant (76.9% vs. 19.1%, P < 0.0001). Normal EF domain scores (≥26) at study end were achieved by 32.7% and 9.4% in the mirodeniafl and placebo groups, respectively (P = 0.0031). As for the LSC scores, the mirodenafil group showed significantly greater improvements in sexual life and partner relationship than the placebo group. Most treatment-associated AEs were mild that resolved spontaneously. Conclusions. Mirodenafil is an effective and well-tolerated agent for the treatment of diabetic patients with ED in Korea. Park HJ, Choi HK, Ahn TY, Park JK, Chung WS, Lee SW, Kim SW, Hyun JS, and Park NC. Efficacy and safety of oral mirodenafil in the treatment of erectile dysfunction in diabetic men in Korea: A multicenter, randomized, double-blind, placebo-controlled clinical trial.
KW - Diabetes: Diabetes Mellitus and Erectile Dysfunction
KW - Erectile Dysfunction
KW - Mirodenafil
KW - PDE5
UR - http://www.scopus.com/inward/record.url?scp=77955264828&partnerID=8YFLogxK
U2 - 10.1111/j.1743-6109.2010.01888.x
DO - 10.1111/j.1743-6109.2010.01888.x
M3 - Article
C2 - 20626604
AN - SCOPUS:77955264828
SN - 1743-6095
VL - 7
SP - 2842
EP - 2850
JO - Journal of Sexual Medicine
JF - Journal of Sexual Medicine
IS - 8
ER -
